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62 SMT007 MAGAZINE I MAY 2019 One of the fundamental current good man- ufacturing practices (CGMPs) that medical device manufacturers implement are robust process validation procedures. Medical OEM manufacturers typically have deployed effec- tive process validation systems in their oper- ations; however, contract manufacturers may struggle to deploy effective process validation systems in their operations. The column pro- vides a practical guideline on how to effectively implement a sustainable process validation program for contract manufacturers. A robust but practical process validation program can make a contract manufacturer achieve consis- tent, high-quality performance. The quest for each manufacturer is to grow its business by establishing robust processes that yield consistent and reliable parts meet- ing customer drawing specifications and pur- chase order requirements. This statement sounds straightforward conceptually but can be a daunting task in practice. Having audited, managed, or consulted with over 100 factories in the last 20 years, I have found a common theme that defines top performing manufactur - ing plants. Top-performing manufacturers have practical and consistent methods in implement- ing, validating, and monitoring processes. Con- Process Validation Can Lead to Higher Performance Levels tract manufacturers can significantly improve the quality and consistency of their parts by having a robust and effective process valida- tion program. Before we evaluate an effective approach to process validation, it is important to under- stand the quality system requirements of vali- dation. In the ISO 9001:2015 standard—Clause 8.5.1—on control of production and service provision, there is a requirement for you to have controlled conditions for "validation and periodic revalidation of the ability to achieve planned results of the processes for produc- tion and service provision where the resulting output cannot be verified by subsequent mon- itoring or measurement." In regulated indus- tries, such as aerospace and medical devices, specific process validation requirements are called out in AS9100D—aerospace standard— Clause "Validation and Control of Spe- cial Processes," and ISO 13485:2016—medical devices, quality management systems—Clause 7.5.6 "Validation of Processes for Production and Service Provision." The FDA made process validation a regu- latory requirement in CFR 820.75(a), process validation with supplemental guidance for industry—"Process Validation: General Prin- In Search of Operational Excellence by Alfred Macha, AMT PARTNERS Alfred Macha is the president of AMT Partners debuting his first column in this month's issue. Look forward to more insights from Alfred in future magazines. He can be reached at

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